Trial Outcomes & Findings for Doxorubicin (Doxil) Combined With Rituxan, Cyclophosphamide, Vincristine and Prednisone in Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas (NCT NCT00184002)

Last Updated: 2017-08-10

Results Overview

Initial disease response tests will be performed after cycle 4 on all patients. Subsequent assessments after cycles 6 and/or 8 will depend on response. If after 4 cycles of therapy complete response or partial response has been documented, therapy will continue. If stable or progressive disease has been documented, the patient will be withdrawn from the study. Response to the study treatment will be determined according to the criteria proposed in the "Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas" by Cheson et al (23).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

68 participants

Primary outcome timeframe

At completion of cycle 4, 6, and 8

Results posted on

2017-08-10

Participant Flow

The study began recruiting in January 2003 and ended in December 2007. All subjects were seen and treated either at USC Norris Comprehensive Cancer Center or at LAC+USC Medical Center.

There were no pre-assignment criteria. All subjects were given the same treatment.

Participant milestones

Participant milestones
Measure	DR-COP On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5. On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5 * 1 cycle = 21 days. * Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles. Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min. Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min. Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum). Prednisone 100 mg po days 1-5. Cycle 2 until study completion Doxil 40 mg/m2 iv day 1 Rituxan 375 mg/m2 iv day 1 Cyclophosphamide 750 mg/m2 iv day 1
Overall Study STARTED	68
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Reasons for withdrawal
Measure	DR-COP On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5. On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5 * 1 cycle = 21 days. * Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles. Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min. Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min. Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum). Prednisone 100 mg po days 1-5. Cycle 2 until study completion Doxil 40 mg/m2 iv day 1 Rituxan 375 mg/m2 iv day 1 Cyclophosphamide 750 mg/m2 iv day 1
Overall Study Adverse Event	9
Overall Study Death	3
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Doxorubicin (Doxil) Combined With Rituxan, Cyclophosphamide, Vincristine and Prednisone in Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DR-COP n=68 Participants On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5. On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5 * 1 cycle = 21 days. * Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles. Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min. Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min. Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum). Prednisone 100 mg po days 1-5. Cycle 2 until study completion Doxil 40 mg/m2 iv day 1 Rituxan 375 mg/m2 iv day 1 Cyclophosphamide 750 mg/m2 iv day 1
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	48 Participants n=5 Participants
Region of Enrollment United States	68 participants n=5 Participants

PRIMARY outcome

Timeframe: At completion of cycle 4, 6, and 8

Outcome measures

Outcome measures
Measure	DR-COP n=68 Participants On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5. On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5 * 1 cycle = 21 days. * Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles. Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min. Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min. Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum). Prednisone 100 mg po days 1-5. Cycle 2 until study completion Doxil 40 mg/m2 iv day 1 Rituxan 375 mg/m2 iv day 1 Cyclophosphamide 750 mg/m2 iv day 1
Percentage of Patients With Complete Response to the Combination Chemotherapy Complete Response	75.0 Percentage of participants
Percentage of Patients With Complete Response to the Combination Chemotherapy Partial Response	23.0 Percentage of participants

SECONDARY outcome

Timeframe: At end of every cycle

Summary of grade 3 or higher toxicities (per Common Toxicity Criteria version 2.0) which generally is described as severe adverse reaction or symptom.

Outcome measures

Outcome measures
Measure	DR-COP n=68 Participants On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5. On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5 * 1 cycle = 21 days. * Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles. Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min. Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min. Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum). Prednisone 100 mg po days 1-5. Cycle 2 until study completion Doxil 40 mg/m2 iv day 1 Rituxan 375 mg/m2 iv day 1 Cyclophosphamide 750 mg/m2 iv day 1
Number of Patients With Serious Adverse Events as a Measure of Safety and Tolerability	35 Participants

Adverse Events

DR-COP

Serious events: 35 serious events

Other events: 27 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	DR-COP n=68 participants at risk On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5. On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5 * 1 cycle = 21 days. * Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles. Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min. Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min. Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum). Prednisone 100 mg po days 1-5. Cycle 2 until study completion Doxil 40 mg/m2 iv day 1 Rituxan 375 mg/m2 iv day 1 Cyclophosphamide 750 mg/m2 iv day 1
Hepatobiliary disorders SGOT (AST) (serum glutamic oxaloacetic transaminase)	4.4% 3/68 • Number of events 3 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Hepatobiliary disorders SGPT (ALT) (serum glutamic pyruvic transaminase)	4.4% 3/68 • Number of events 3 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Stomatitis/pharingitis (oral/pharyngeal mucositis)	2.9% 2/68 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Abdominal pain or cramping	2.9% 2/68 • Number of events 4 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	51.5% 35/68 • Number of events 42 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Metabolism and nutrition disorders Anorexia	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Hepatobiliary disorders Bilirubin	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Cardiac disorders Cardiac left ventricular function	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Investigations Cardiac troponin I (cTnl)	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Metabolism and nutrition disorders Dehydration	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Diarrhea patients without colostomy	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	8.8% 6/68 • Number of events 6 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
General disorders Fatigue (lethargy, malaise, asthenia)	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Infections and infestations Febrile neutropenia	11.8% 8/68 • Number of events 8 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Skin and subcutaneous tissue disorders Hand-foot skin reaction	14.7% 10/68 • Number of events 10 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Blood and lymphatic system disorders Hemoglobin	16.2% 11/68 • Number of events 13 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Metabolism and nutrition disorders Hyperglycemia	2.9% 2/68 • Number of events 5 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Cardiac disorders Hypertension	2.9% 2/68 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Metabolism and nutrition disorders Hypocalcemia	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Metabolism and nutrition disorders Hypokalemia	4.4% 3/68 • Number of events 5 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Metabolism and nutrition disorders Hyponatremia	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Metabolism and nutrition disorders Hypophosphatemia	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Cardiac disorders Hypotension	2.9% 2/68 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.9% 2/68 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Ileus (or neuroconstipation)	2.9% 2/68 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Renal and urinary disorders Incontinence	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Infections and infestations Infection	11.8% 8/68 • Number of events 8 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Infections and infestations Infection without neutropenia	8.8% 6/68 • Number of events 6 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Blood and lymphatic system disorders Leukocytes (total WBC)	1.5% 1/68 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Melena/GI bleeding	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Musculoskeletal and connective tissue disorders Myalgia (muscle pain)	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Nausea	2.9% 2/68 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Nervous system disorders Neuropathy-sensory	2.9% 2/68 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Blood and lymphatic system disorders Platelets	7.4% 5/68 • Number of events 9 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	1.5% 1/68 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Metabolism and nutrition disorders Tumor lysis syndrome	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Renal and urinary disorders Ureteral obstruction	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Respiratory, thoracic and mediastinal disorders Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Vomiting	2.9% 2/68 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
General disorders Weight loss	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.

Other adverse events

Other adverse events
Measure	DR-COP n=68 participants at risk On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5. On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5 * 1 cycle = 21 days. * Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles. Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min. Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min. Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum). Prednisone 100 mg po days 1-5. Cycle 2 until study completion Doxil 40 mg/m2 iv day 1 Rituxan 375 mg/m2 iv day 1 Cyclophosphamide 750 mg/m2 iv day 1
Gastrointestinal disorders Abdominal pain or cramping	17.6% 12/68 • Number of events 14 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Hepatobiliary disorders Alkaline phosphatase	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Metabolism and nutrition disorders Alkalosis (metabolic or respiratory)	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
General disorders Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Skin and subcutaneous tissue disorders Alopecia	35.3% 24/68 • Number of events 30 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Metabolism and nutrition disorders Anorexia	23.5% 16/68 • Number of events 19 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Musculoskeletal and connective tissue disorders Arthralgia (joint pain)	7.4% 5/68 • Number of events 5 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Ascites (non-malignant)	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Hepatobiliary disorders Bilirubin	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Musculoskeletal and connective tissue disorders Bone pain	7.4% 5/68 • Number of events 11 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Cardiac disorders Cardiac left ventricular function	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
General disorders Chest pain (non-cardiac and non-pleuritic)	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Eye disorders Conjunctivitis	4.4% 3/68 • Number of events 3 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Constipation	27.9% 19/68 • Number of events 25 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Respiratory, thoracic and mediastinal disorders Cough	11.8% 8/68 • Number of events 8 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Renal and urinary disorders Creatinine	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Metabolism and nutrition disorders Dehydration	1.5% 1/68 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Diarrhea patients without colostomy	17.6% 12/68 • Number of events 16 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Nervous system disorders Dizziness/lightheadedness	5.9% 4/68 • Number of events 4 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Eye disorders Dry eye	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Dyspepsia/heartburn	10.3% 7/68 • Number of events 7 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Dysphagia, esophagitis, odynophagia (painful swallowing)	7.4% 5/68 • Number of events 5 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	13.2% 9/68 • Number of events 9 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Renal and urinary disorders Dysuria (painful urination)	2.9% 2/68 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
General disorders Edema	16.2% 11/68 • Number of events 16 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
General disorders Fatigue (lethargy, malaise, asthenia)	32.4% 22/68 • Number of events 32 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
General disorders Fever	16.2% 11/68 • Number of events 12 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Flatulence	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Skin and subcutaneous tissue disorders Hand-foot skin reaction	26.5% 18/68 • Number of events 23 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Nervous system disorders Headache	20.6% 14/68 • Number of events 17 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Blood and lymphatic system disorders Hemoglobin	33.8% 23/68 • Number of events 42 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Respiratory, thoracic and mediastinal disorders Hemoptysis	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Injury, poisoning and procedural complications Hemorrhage/bleeding	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Endocrine disorders Hot flashes/flushes	2.9% 2/68 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Metabolism and nutrition disorders Hypercalcemia	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Metabolism and nutrition disorders Hypercholesterolemia	2.9% 2/68 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Metabolism and nutrition disorders Hyperglycemia	22.1% 15/68 • Number of events 27 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Metabolism and nutrition disorders Hypermagnesemia	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Cardiac disorders Hypertension	7.4% 5/68 • Number of events 5 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Hepatobiliary disorders Hypoalbuminemia	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Metabolism and nutrition disorders Hypocalcemia	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Metabolism and nutrition disorders Hypokalemia	8.8% 6/68 • Number of events 7 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Metabolism and nutrition disorders Hypomagnesemia	2.9% 2/68 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Metabolism and nutrition disorders Hypophosphatemia	1.5% 1/68 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Cardiac disorders Hypotension	4.4% 3/68 • Number of events 3 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Ileus (or neuroconstipation)	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Renal and urinary disorders Incontinence	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Infections and infestations Infection without neutropenia	13.2% 9/68 • Number of events 15 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Psychiatric disorders Insomnia	22.1% 15/68 • Number of events 16 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Blood and lymphatic system disorders Leukocytes (total WBC)	1.5% 1/68 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Melena/GI bleeding	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Psychiatric disorders Mood alteration-anxiety, agitation	2.9% 2/68 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Psychiatric disorders Mood alteration-depression	4.4% 3/68 • Number of events 3 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Mouth dryness	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Musculoskeletal and connective tissue disorders Muscle weakness (not due to neuropathy)	5.9% 4/68 • Number of events 5 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Musculoskeletal and connective tissue disorders Myalgia (muscle pain)	2.9% 2/68 • Number of events 3 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Nausea	32.4% 22/68 • Number of events 37 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Nervous system disorders Neuropathy-motor	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Nervous system disorders Neuropathy-sensory	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	27.9% 19/68 • Number of events 34 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
General disorders Pain due to radiation	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Skin and subcutaneous tissue disorders Pigmentation changes (e.g., vitiligo)	2.9% 2/68 • Number of events 4 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
General disorders Pain	39.7% 27/68 • Number of events 63 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Blood and lymphatic system disorders Platelets	8.8% 6/68 • Number of events 14 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Respiratory, thoracic and mediastinal disorders Pleural Effusion (non-malignant)	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Skin and subcutaneous tissue disorders Pruritus	5.9% 4/68 • Number of events 4 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Skin and subcutaneous tissue disorders Rash/desquamation	13.2% 9/68 • Number of events 10 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
General disorders Rigors, chills	4.4% 3/68 • Number of events 3 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Sense of smell	2.9% 2/68 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Hepatobiliary disorders SGOT (AST) (serum glutamic oxaloacetic transaminase)	7.4% 5/68 • Number of events 7 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Hepatobiliary disorders SGPT (ALT) (serum glutamic pyruvic transaminase)	7.4% 5/68 • Number of events 8 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Cardiac disorders Sinus bradycardia	4.4% 3/68 • Number of events 3 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Cardiac disorders Sinus tachycardia	10.3% 7/68 • Number of events 10 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Injury, poisoning and procedural complications Skin-Laate RT Morbidity Scoring	2.9% 2/68 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Stomatitis/pharyngitis (oral/pharyngeal mucositis)	25.0% 17/68 • Number of events 24 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
General disorders Sweating (eiaphoresis)	2.9% 2/68 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Taste disturbance (dysgeusia)	20.6% 14/68 • Number of events 17 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Cardiac disorders Thrombosis/embolism	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Renal and urinary disorders Urinary frequency/urgency	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Renal and urinary disorders Urinary retention	2.9% 2/68 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Eye disorders Vision-blurred vision	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Respiratory, thoracic and mediastinal disorders Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Vomiting	20.6% 14/68 • Number of events 22 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
General disorders Weight loss	2.9% 2/68 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Infections and infestations Wound-infectious	1.5% 1/68 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.

Additional Information

Victoria Soto - Project Specialist

USC Norris Comprehensive Cancer Center

Phone: (323) 865-0454

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place